dinox consultancy advises on product development, study design, data interpretation and other issues in female health research, and on issues concerning the female population in clinical studies in general. Additionally, medical writing services and training sessions are provided.
Both experts have each more than 30 years of experience in the conduct of clinical studies in the female population. They have gained extensive knowledge of gynaecological endocrinology and of compounds registered in this field. They have access to a well-established network of experts in all areas of drug development from the preclinical phase until post-registration marketing.
Based upon their experience and knowledge, dinox consultancy advises on
- product development in female health research
- study design development and optimalisation
- research protocol and other trial documents
- choice of pharmacodynamic parameters
- data interpretation
- scientific issues in the area of gynaecological endocrinology and female sexual health
- issues concerning the female population in clinical studies in general, e.g.
- logistics of cycle-dependent study drug administration and assessments
- contraception in clinical studies
- emergency measures in cases of failed contraception
- recruitment strategies
- optimalisation of trial logistics
- optimisation of company processes in clinical research
- reply to questions by the authorities
- preparation of authority audits
dinox consultancy provides medical writing services:
- protocol writing
- writing of informed consent form
- writing of scientific publications
dinox consultancy provides training sessions on
- women in clinical trials: guidelines, background, characterization of fertility status, implementing the guidelines in practice, challenges in practice
- interaction studies with oral contraceptives: background, design, interpretation
- contraceptive use during the conduct of clinical trials
- biomarkers for the contraceptive effect
- study design for the development of hormonal contraceptives
Other topics can be addressed upon request.
Christine Klipping, MD PhD, Chief Executive Officer
Dr Klipping, founder of dinox consultancy in 2013, has over 30 years of experience in gynaecological endocrinology and in vaginal ultrasonography. She graduated in medicine in 1988, and in 1992 completed her thesis at the University of Lübeck, Germany, on the subject of “Determination of Catecholestrogens in human follicular fluid”. In 1988 and 1989 she worked as a resident at the department of Prenatal Diagnostics and Therapy, and at the department of Obstetrics and Gynecology of the University of Bonn, Germany. From 1990-1991 she was responsible for several human-pharmacology studies. In 1992 research work was continued in the Netherlands, at the department of Obstetrics and Gynecology of the Catholic University of Nijmegen. In 1993 she performed bio-equivalence and bio-availability studies at the Research Centre for Oral Contraceptives, Nijmegen, the Netherlands. In the same year Dr. Klipping founded her own independent Clinical Research Organisation: dinox. Dr Klipping is frequently consulted for her know-how in gynaecological endocrinology, trial designs and related pharmacodynamic assessments. She has been extensively involved in clinical development programs for several pharmaceutical companies.
Dr Klipping is a member of several associations including the AGAH (Arbeitsgemeinschaft für Angewandte Humanpharmakologie, Germany) and since 1997 a member of the AGAH Board of Directors.
Ingrid Duijkers, MD PhD, Chief Operating Officer
Dr Duijkers joined dinox in 1995 and co-founded dinox consultancy. After finishing her medical studies at the Catholic University of Nijmegen in 1989, she was a resident at the department of Obstetrics and Gynecology at the University Hospital of Nijmegen. In 1989 she started her work as an IVF physician at the same department, which she continued until 1997. From 1993 to 1995 she was employed at an outpatient clinic for fertility disorders. She performed research in addition to the clinical activities. From 1989 to 1990 she investigated the effect of monoclonal antibodies on sperm-zona pellucida interaction in the laboratory of endocrinology and reproduction. Thereafter she started her Ph.D. studies, in IVF-patients as well as volunteers resulting in a thesis entitled “Gonadotrophins, some Basic and Clinical Aspects” in 1995.
Dr Duijkers has over 30 years of experience in vaginal ultrasonography and gynaecological endocrinology. She is responsible for the scientific publications. Dr Duijkers is a member of several scientific associations.
Contact dinox consultancy:
dinox consultancy bv
6524 HW Nijmegen
+31(0) – 6 22411521